EarlyCDT® Frequently Asked Questions section
This page contains answers to commonly-asked questions about EarlyCDT® platform.
Please do not forget to check EarlyCDT®-Lung FAQ section and EarlyCDT®-Breast FAQ section.
Is the EarlyCDT® procedure covered by insurance?
At this time, insurance carriers do not cover EarlyCDT®; however, you may wish to advise your patient to contact his or her insurance company to discuss whether the opportunity for assistance exists.
EarlyCDT® be covered by a corporate health savings account. Your patients will need a receipt showing the cost incurred for the test to obtain reimbursement from a health savings account.
When can I expect to receive the EarlyCDT® results?
Oncimmune® has partnered with FedEx to provide overnight delivery of samples to the laboratory. A tracking number will be given to your patient when his or her blood is drawn for his or her information and follow-up purposes. You can expect the test results to be sent to you in about a week of the Oncimmune®laboratory receiving the sample from the draw station. If you have any concerns about the delivery of the sample, please contact Oncimmune®'s Client Services Department at (888) 583-9030, Monday through Friday, 8:00 a.m. to 5:00 p.m. CST.
Do you accept payment arrangements?
Currently, Oncimmune®is set up to accept credit cards, checks or money orders. We are also considering alternate payment options such as bill me later for our clients.
What is the best way to share test results with my patient?
We suggest simply indicating that the results are positive or negative and providing the Understanding Your Results document that comes with the Results Report. We have developed the Results Report as a way to track results over time and collect data essential to expanding the interpretive power of EarlyCDT®. At this time, however, the data supports only a positive or a negative result.
If an autoantibody level is negative, is there cause for concern if the level is above the minimum or approaches the cutoff value?
At this time, the data does not support such an interpretation of relative levels with respect to positivity or negativity.
Is one antigen on the test panel more relevant to disease diagnosis than another?
If one or more of the autoantibodies to a specific antigen are present at a level above the cutoff value, then the result is positive and suggests the presence of the disease. At this time, each autoantibody level is equally relevant.
Why does the EarlyCDT® panel contain specific autoantibodies?
The antigens in each EarlyCDT® panel have been selected for their involvement in the early stages of the development of tumor formation and thus are believed to be well-suited for the early detection of that particular cancer. Due to the heterogeneous nature of cancer, the diagnostic power of the test is greatly enhanced by the combination of autoantibodies.
What forms of payment are accepted?
- Credit Cards VISA, MasterCard
- Cheques personal cheque, cashier's cheque
- Money Order
- Cash will not be accepted
How soon should the patient have his or her sample taken after purchasing EarlyCDT® online?
The time frame from ordering the test and having the patient's blood drawn for testing is a decision the patient should make in consultation with his or her physician. Keep in mind that if paying with a credit card, the credit card used to purchase the test online will be charged at the time of purchase.
(See “terms and conditions” online for more information regarding the transaction) We estimate allowing 1 week for the physician to receive the test result(s) once the sample is received in the Oncimmune® laboratory. (Each patient's situation and sample is unique, and therefore, test results cannot be guaranteed by a specific date).
How does the patient pay for the test if not done through the website?
When a patient has his or her blood drawn for the test, they will need to fill out the payment portion of the Test Requisition Form (TRF), tear or cut off the payment portion and provide to the laboratory for payment verification. Once the laboratory has verified the payment and collected the tender (if applicable), insert both the tender and tear off from the TRF in the payment envelope provided in the collection kit. The payment will need to accompany the sample in the collection kit and be sent to Oncimmune®'s laboratory facility for testing.
Can a patient fill out the Test Requisition Form on the website and make payment later?
Yes, when the patient has his or her blood drawn, there will be a payment envelope provided where the credit card info can be supplied or check inserted.
How are the questions on the requisition form relevant to EarlyCDT®?
The questions on the requisition form are designed to provide a snapshot of the patient history as needed when completing any health assessment. Oncimmune® believes the clinical data obtained will assist the oncology staff when handling a positive result. For example, if the Oncimmune® EarlyCDT® is positive and diagnostic imaging is negative, the physician can quickly look at the clinical data and determine the best approach for future testing.
Where is the sample for EarlyCDT® sent for testing?
The sample is sent to Oncimmune®'s laboratory located in the Greater Kansas City area for testing, analysis and reporting. Though final stability studies are ongoing, we expect that the sample can be sent at ambient temperature via FedEx. Oncimmune® will cover the cost of the overnight FedEx shipment and shipping materials. A collection kit will be provided with the necessary instructions and materials for shipment.
How are the patient results reported?
The test is reported to the physician as either a negative or positive result via facsimile, mail, or through the physician's online portal. The test report will include the results for all of the measured autoantibodies. The results reported through the online portal on the website are secure and require a physician to have an access code to login.
What is the cost to the patient for EarlyCDT®?
Since EarlyCDT® is a cutting edge new technology; we have not established reimbursement with insurance carriers at this time though we plan to pursue reimbursement in the future. EarlyCDT® is may be covered under an employers' health savings account (HSA) or Flexible savings account (FSA) and patients should be able to receive reimbursement under those programs if they participate with his or her employers.
EarlyCDT® does have established, applicable CPT codes and though we have not tested reimbursement directly with carriers we do expect that some patients will attempt submission and may receive payment. That being said, we are releasing EarlyCDT® as a self–pay test and do not expect immediate reimbursement form carriers. We are still in the process of finalizing pricing as we complete the analysis of focus group inputs, market comparisons, reimbursement potential and economic modeling.
1 Chapman, C., et al., March 2007, “Autoantibodies in Lung Cancer: his or her Use as an Aid to Early Diagnosis.” Annals of Oncology (online publication), 18:868–873